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Clinical Trials in Poland / NCT04943211
Active, not recruiting Phase 3

Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging

NCT04943211 · tracked via the Priya Life Science Poland tracker
Sponsor
Anna Raciborska
Phase
Phase 3
Started
2021-04-01
Last updated
2026-10-07

Condition(s) studied

Histiocytosis

Investigational drug(s) / intervention(s)

fluorodeoxyglucose (18F-FDG) →

fluorodeoxyglucose (18F-FDG): max 6 MGBq/kg, no more than 100

Study summary

Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the tumor tissues, monitoring its presence in free-circulating DNA, and determining the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging.

Eligibility

Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patient under 18 years of age at the time of inclusion. 2. Histopathologically confirmed or suspected histiocytosis (based on prior test results). 3. Signing of informed consent for trial participation according with current legal regulations. Exclusion Criteria: 1. Lack of inclusion criteria. 2. Pregnancy. 3. Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.

Primary outcome measure(s)

  • EFS - (event-free survival) — 2 years
    Event-free survival (EFS) was defined as the time interval from the date of diagnosis to the date of disease progression, recurrence, second malignancy, death or to date of last follow-up for patients without events.

Trial sites (1)

FacilityCityRegionStatus
Mother and Child Institute Warsaw Mazovian

More Anna Raciborska trials in Poland

Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis Active, not recruiting
Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma Recruiting
Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients Active, not recruiting
To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly) Recruiting

Other trials for the same condition

Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis Active, not recruiting
Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04943211 on ClinicalTrials.gov ↗ ← All trials in Poland